ProdiGI ERD-TWSG

GUDID 10884521808386

Grasper, ERD-TWSG, Secondary Grasper

Covidien LP

Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor Internally-anchored endoscopic retractor

• Primary Device ID: 10884521808386
• NIH Device Record Key: 9650e70b-d132-42e0-8cb1-238c83bd4900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProdiGI
• Version Model Number: ERD-TWSG
• Catalog Number: ERD-TWSG
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
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• Special Storage Condition, Specify: Between 0 and 0 *
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 22 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521808386 [Primary]
GS1	20884521808383 [Package]; Package: CS [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220006

FDA Product Code

• PTS: Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
• QSW: Endoscopic Traction Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-03-01
• Device Publish Date: 2020-07-10

On-Brand Devices [ProdiGI]

• 10884521806870: Wire, ERD-TW35, Traction Device 35mm
• 10884521806863: Wire, ERD-TW20, Traction Device 20mm
• 20884521808383: Grasper, ERD-TWSG, Secondary Grasper
• 10884521808386: Grasper, ERD-TWSG, Secondary Grasper
• 20884521808406: Traction Magnet
• 20884521808390: Traction Magnet